2023 年第 2 期 第 18 卷

氟比洛芬凝胶贴膏治疗膝骨关节炎的药品临床综合评价

Clinical comprehensive evaluation of flurbiprofen cataplasms in the treatment of knee osteoarthritis

作者：吴紫阳程吟楚易湛苗翟所迪

英文作者：Wu Ziyang Cheng Yinchu Yi Zhanmiao Zhai Suodi

单位：北京大学第三医院药剂科北京大学医学部药物评价中心，北京100191

英文单位：Department of Pharmacy Peking University Third Hospital Institute for Drug Evaluation Peking University Health Science Center Beijing 100191 China

关键词：氟比洛芬凝胶贴膏；洛索洛芬钠凝胶贴膏；吲哚美辛巴布膏；膝骨关节炎；药品临床综合评价

英文关键词：Flurbiprofencataplasms;Loxoprofensodiumcataplasms；Indomethacincataplasms；Kneeosteoarthritis;Clinicalcomprehensiveevaluationofdrug

• 摘要：

• 目的 对氟比洛芬凝胶贴膏治疗膝骨关节炎进行综合评价，为临床用药决策提供证据支持。方法 系统检索PubMed、中国知网等中英文数据库，由2名研究者独立进行文献筛选、数据提取和质量评价。采用定性描述方法，从有效性、安全性、经济性、创新性、适宜性和可及性6个维度对氟比洛芬凝胶贴膏治疗膝骨关节炎进行综合评价。结果 检索到374篇文献，最终共纳入2项随机对照试验研究和1项药物经济学研究。有效性方面，与吲哚美辛巴布膏相比，氟比洛芬凝胶贴膏显著改善了患者的疼痛视觉模拟量表（VAS）评分（P＜0.01），但在关节僵硬评分及关节功能障碍评分方面差异均无统计学意义（均P＞0.05）；与洛索洛芬钠凝胶贴膏相比，氟比洛芬凝胶贴膏可显著改善患者VAS评分和西安大略和麦克马斯特大学骨关节炎指数评分。安全性方面，氟比洛芬凝胶贴膏患者皮肤红肿、斑疹、疼痛等局部不良反应发生率均显著低于洛索洛芬钠凝胶贴膏，贴敷束缚感优于吲哚美辛巴布膏（均P＜0.05）。经济性方面，与吲哚美辛巴布膏相比，氟比洛芬凝胶贴膏增量成本效用比为-139 041.10元/质量调整生命年，具有经济学优势。3种药物的日治疗费用分别为氟比洛芬凝胶贴膏19.10元，吲哚美辛巴布膏11.31～22.62元、洛索洛芬钠凝胶贴膏24.25元。氟比洛芬凝胶贴膏在剂型方面有所创新，使用方便，气味小，不污染衣物，束缚感低，从而提高了患者的依从性；目前已被纳入医保目录，覆盖医院范围广，可及性良好。结论 氟比洛芬凝胶贴膏可显著改善膝骨关节炎患者的疼痛，局部不良反应发生率低，具有经济学优势，且适宜性和可获得性良好。

• Objective To comprehensively evaluate the treatment of knee osteoarthritis with flurbiprofen cataplasms and to provide evidence support for clinical medication decisions. Methods  PubMed, China National Knowledge Infrastructure and other Chinese and English databases were systematically searched. Two researchers independently conducted literature selection, data extraction and quality evaluation. Qualitative description method was used to comprehensively evaluate the efficacy, safety, economy, innovation, suitability and accessibility of flurbiprofen cataplasms in the treatment of knee osteoarthritis. Results  A total of 374 literatures were searched and 2 randomized controlled trials and 1 economic evaluation research were included finally. In terms of efficacy, flurbiprofen cataplasms significantly improved patients′ pain visual analogue scale (VAS) score compared to indometacin cataplasms （P＜0.01）, while the differences between the two interventions were not statistically significant in terms of the joint stiffness and joint dysfunction scores（both P＞0.05）. Compared to loxoprofen sodium cataplasms, flurbiprofen cataplasms significantly improved VAS and the Western Ontario and McMaster Universities Arthritis Index scores. In terms of safety, flurbiprofen cataplasms showed significantly less redness, swelling, efflorescence, and pain compared to loxoprofen sodium cataplasms, and flurbiprofen cataplasms was more comfortable than indomethacin cataplasms in sense of constriction（all P＜0.05）. Economically, compared to indomethacin cataplasms, the incremental cost utility ratio of flurbiprofen cataplasms was -139 041.10 yuan/quality-adjusted life year. Flurbiprofen cataplasms had an economic advantage over indomethacin cataplasms in the treatment of knee osteoarthritis. The daily treatment costs of flurbiprofen cataplasms， indomethacin cataplasms and loxoprofen sodium cataplasms were 19.10 yuan, 11.31-22.62 yuan and 24.25 yuan respectively. Flurbiprofen cataplasms was innovative in terms of dosage form and was easy to use with less odour, non-contaminating clothing and less sense of constriction, thus improving patient compliance. Flurbiprofen cataplasms was also included in the National Reimbursement Drug List with wide hospital coverage and good accessibility. Conclusion  Flurbiprofen cataplasms significantly improves pain in patients with knee osteoarthritis, has a low incidence of local adverse effects, offers economic advantages, and has good appropriateness and accessibility.